A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy

Ovarian Cancer Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of Fluzoparib±Apatinib for Maintenance Treatment in Patients With Advanced Ovarian Cancer Who Have Achieved Effective Response After First-line Platinum-containing Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04229615
• Other study ID #: FZPL-?-302
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 2, 2020
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, blinded, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Placebo, as maintenance treatment, in patients with Stage III or IV ovarian cancer. Patients must have completed first-line platinum based regimen with Complete Response (CR) or Partial Response (PR). The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 690
• Est. completion date: April 1, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• (phase 3)Histologically new diagnosed, advanced (FIGO Stage III or IV) high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)

• (phase 3)Complete response (CR) or partial response (PR) achieved with front-line platinum-based chemotherapy regimen as determined by investigator

• (phase 3)Ability to be randomized =8 weeks after last dose of platinum

• (Saftey Lead-in)Received 2~4 prior chemotherapy regimens. Platimun sensitive relapsed; Have at least one measurable disease as defined by RECIST v1.1.

Exclusion Criteria:

• Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib

• Patients who have received other study drug treatment within 4 weeks prior to the first administration(< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs).

• Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

Intervention

Drug:
• Fluzoparib; Apatinib
Drug: Fluzoparib Orally twice daily; Apatinib Orally once daily
• Fluzoparib
Fluzoparib Orally twice daily
• Placebo
Placebo

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Safety Lead-in) Incidence of =3 grade TRAEs	Incidence of =3 grade treatment related adverse events	up to 28 days after the last patient of the lead-in phase
Primary	(Phase 3) Progression free survival(PFS) in advanced ovarian cancer patients	Defined as progression free survival per RECIST 1.1 criteria according to BIRC criteria	up to 4 years
Secondary	AEs+SAEs	Adverse Events and Serious Adverse Events	from the first drug administration to within 30 days for the last treatment dose
Secondary	PFS by investigator's assessment	Progression-Free-Survival	up to 4 years
Secondary	OS	OS is the time interval from the start of treatment to death due to any reason or lost of follow-up	up to 6 years
Secondary	Patients reported outcome(PROs)assessed by EQ-5D-5L questionnaire	Comparison of the Quality of Life in study arms assessed by EQ-5D-5L questionnaire	48 months
Secondary	Patients reported outcome(PROs)assessed by FOSI questionnaire	Comparison of the Quality of Life in study arms assessed by FOSI questionnaire	48 months
Secondary	Time to progression on the next anticancer therapy (PFS2) From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.	From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.	4 years